No Opioids PrescrIptions On Discharge After Surgery

Surgery Clinical Trial

— NOPIOiDS  

Official title:

Prospective Study of No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04469868
• Other study ID #: 5866
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Albany Medical College
• Contact: Badar M. Mian, MD
• Phone: 515-262-7558
• Email: mianb[@]amc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Opioid analgesics are routinely prescribed for these patients for post-operative pain control. Even a short exposure to opioids in opioid-naïve patients following minor or major surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of patients. The goal of the study to eliminate the use of outpatient opioids prescriptions after major urologic surgery.

Description:

Nearly 200 million opioid prescriptions are dispensed per year in the United States. Opioid prescriptions given by medical providers are a major contributor to the opioid abuse epidemic. Nearly 40% of opioid overdose-related deaths occur due to prescribed opioids. Among patients diagnosed with opiate dependence, 80% had received an opioid prescription prior to their abuse diagnosis and 51% had a family member who had an opioid prescription, Thus, opioids prescriptions, which are often in excess of the need by the patient, are a major contributor to this public health crisis. The investigators devised a prospective intervention study to eliminate or significantly reduced the use of opioids prescribed at hospital discharge after major urologic surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing major urologic cancer surgery, either open or laparoscopic, will be included in the study.
• This will include all open or laparoscopic or robotic surgery including radical prostatectomy, radical cystectomy, radical nephrectomy, partial nephrectomy, nephron-ureterectomy, and similar procedures.

Exclusion Criteria:

• Those with allergy or intolerance to NSAIDS may be excluded.

Related Conditions & MeSH terms

• Opioid Use
• Postoperative Pain
• Prescription Drug Abuse and Dependency
• Substance-Related Disorders
• Surgery

Intervention

Behavioral:
• No opioids at discharge
Patients who are being scheduled for any major urologic cancer surgery (open or laparoscopic) will be counselled regarding post-operative pain and measures taken during surgery and during hospital stay. They will be provided written information on these pain mitigation efforts and the adverse effects associated with opioids use and outpatient prescriptions. Patients will be discharged from the hospital without any opioids prescriptions and instructions to use non-opioids analgesics. Patients will complete a visual analog pain scale daily for 7 days after discharge from the hospital. Patients will be able to call the clinic at anytime for any post-operative pain issues.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioids prescribing at hospital discharge	Patients will be discharged with no or few opioids after surgery along with instruction on how to use non-opioid analgesic measures.	30 days
Primary	All opioids prescriptions within 30 days of surgery	The electronic medical records and pharmacy records will be monitored to identify if any additional opioids prescriptions were provided by any provider	30 days
Secondary	Post-operative pain after discharge	Visual analog pain scale (which ranges from 0-10) will be completed daily for 7 days. Score of zero signifies no pain at all and a a score of 10 implies the worst pain ever experienced.	7 days
Secondary	Satisfaction score during home recovery	Overall satisfaction score (0-100%) with post-operative pain, discomfort and recovery at home. A higher score signifies more satisfaction with pain control during the recovery process.	7 days
Secondary	Contact with healthcare facilities	All phone calls to the clinic, unplanned visits, emergency room visits, hospital admissions will recorded and combined as a single measure of contact with any healthcare facility as a measure of resource utilization.	30 days